FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126697–126720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1990
WEINSTEIN STYLE INSTRUMENT HOLDER
K901486 · LDQ
David Ayres Medical Co.
General & Plastic Surgery · 34d
Cleared May 02, 1990
GDC 3084 CASTING ALLOY
K901532 · EJT
Deringer-Ney, Inc.
Dental · 30d
Cleared May 02, 1990
GDC 588 CASTING ALLOY
K901533 · EJT
The J.M. Co.
Dental · 30d
Cleared May 02, 1990
REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
K901575 · GXY
Pioneering Technologies, Inc.
Neurology · 29d
Cleared May 02, 1990
NOVA LITE(TM) ANA KSL
K901596 · DHN
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 02, 1990
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K901674 · KHO
Tosoh Corp.
Chemistry · 22d
Cleared May 02, 1990
LATEX PATIENT EXAMINATION GLOVES
K901750 · LYY
Haikou Latex Factory
General Hospital · 15d
Cleared May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · LEH
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared May 02, 1990
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
K901807 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 12d
Cleared May 01, 1990
DILECTRON URINARY CONDUCTIVITY PROBE
K891681 · JRE
Gyrus Medical , Ltd.
Chemistry · 405d
Cleared May 01, 1990
ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
K900187 · FPA
Advance Medical Designs, Inc.
Radiology · 105d
Cleared May 01, 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188 · FPA
Advance Medical Designs, Inc.
Radiology · 105d
Cleared May 01, 1990
ATS Y ADAPTER CODE #2452
K900299 · CAC
Artium Medical Corp.
Anesthesiology · 99d
Cleared May 01, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · BTM
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared May 01, 1990
I.C. MEDICAL ADJUSTABLE DIRECT COUPLER
K900511 · GEX
I.C Medical, Inc.
General & Plastic Surgery · 88d
Cleared May 01, 1990
SURGILASE YAG 100 IN ORTHOPEDIC SURGERY
K900570 · GEX
Surgilase, Inc.
General & Plastic Surgery · 83d
Cleared May 01, 1990
RADIATION PROTECTION GLASSES
K900970 · KPY
Infab Corp.
Radiology · 60d
Cleared May 01, 1990
RADIATION PROTECTION GLOVES
K900972 · IWP
Infab Corp.
Radiology · 60d
Cleared May 01, 1990
SOLAR SHADES(TM) SUNGLASSES
K901161 · HQY
Blublocker Corp.
Ophthalmic · 49d
Cleared May 01, 1990
LIG/TDM A, B, C
K901212 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 48d
Cleared May 01, 1990
MODIFIED ENTRAPPING FILTER
K901476 · CAH
Cadema Medical Products, Inc.
General Hospital · 41d
Cleared May 01, 1990
LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC
K901484 · JHI
London Diagnostics, Inc.
Chemistry · 33d
Cleared May 01, 1990
ANATOMICAL MALAR IMPLANT
K901662 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 21d
Cleared May 01, 1990
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · IMD
3M Company
Physical Medicine · 14d